Voluntary Compliance Undertaking of Valeant Canada LP to the Patented Medicine Prices Review Board

1.0 Product Summary

1.1. Lodalis (colesevelam hydrochloride) is indicated for the reduction of cholesterol blood level in patients with hypercholesterolemia (Frederickson Type IIa) as an adjunct to diet and lifestyle changes, when the response to these measures has been inadequate, in patients who are not adequately controlled with an HMG-CoA reductase inhibitor (statin) alone, or who are unable to tolerate a statin.

1.2. Canadian Patent 2192592 pertaining to Lodalis was granted to Valeant International Bermuda on November 24, 2009, and will expire on May 24, 2015. Canadian Patent 2191478 pertaining to Lodalis was granted to Valeant International Bermuda on October 16, 2007, and will expire on June 5, 2015.

1.3. Health Canada issued a Notice of Compliance (NOC) for Lodalis on December 28, 2011. Sales in Canada commenced February 6, 2012.

1.4. Valeant Canada LP is the patentee for purposes of the Patent Act and the Patented Medicines Prices Review Board (PMPRB).

2.0 Application of the Excessive Price Guidelines

2.1 The PMPRB’s Human Drug Advisory Panel (HDAP) recommended Lodalis be reviewed as a Slight/No improvement and identified cholestyramine and colestipol as the most appropriate comparators.  

2.2 In accordance with the Guidelines, a Therapeutic Class Comparison (TCC) test and an International Price Comparison (IPC) test were conducted. The results of these tests indicated that the February-June 2012 introductory price exceeded the Guidelines. The national average transaction price (N-ATP) increased beyond that permitted in 2012, resulting in cumulative excess revenues of $101,261.59 as of December 31, 2012.

2.3 The 2013 N-ATP and the Market Specific ATPs (MS-ATPs) were below their respective Non-Excessive Average Prices (NEAPs).  

3.0 Position of Patentee

3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Valeant Canada LP that the price of Lodalis is or was excessive for purposes of the Patent Act.

4.0 Terms of the Voluntary Compliance Undertaking

In order to comply with the Guidelines, Valeant Canada LP agrees to undertake the following:

4.1 To agree that the maximum average potential price (MAPP) and national non-excessive average prices (N-NEAPs) for Lodalis are as follows:  

2012    $1.1286
2013    $1.1388
2014    $1.1440

4.2 To ensure that the price of Lodalis in 2014 remains within the Guidelines at the national level, and in each market where it is sold;  

4.3 To offset cumulative excess revenues received by Valeant for the period from February 6, 2012 to December 31, 2012 the N-ATP of Lodalis was reduced in 2013 to a level below the 2012 N-NEAP at a national level and in each market where it is sold. Consistent with the PMPRB Guidelines, this reduction has resulted in an offset of excess revenues. To offset the remaining $63,119.56 in excess revenues, as of December 31, 2013, by making a payment to Her Majesty in right of Canada in the amount of $63,119.56 within 30 days of the acceptance of this VCU;

4.4 To offset any additional excess revenues received from January 1, 2014, to the date of implementation of this VCU, as calculated by Board Staff, within 30 days of the filing of the January to June 2014 price and sales data;  

4.5 To ensure that the price of Lodalis remains within the Guidelines in all future periods in which Lodalis is under the PMPRB’s jurisdiction.

Signature: [original signed by:]
Name: Richard Lajoie 
Position: V-P Pharma Business Unit
Patentee: Valeant Canada LP
Date: September 2, 2014